Stereotactic Body Radiation With Nelfinavir for Oligometastases

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Nelfinavir

Criteria

Inclusion Criteria

• Patient's tumor(s) to be treated is(are) ≤ 5.0 cm or ≤250 cm3

• Patient must have metastasis at one or more of the following sites: bone, liver, lymph node and/or lung. No more than five lesions will be treated.

• Histological confirmation of malignancy (primary or metastatic tumor).

• Patient may have any prior therapy allowed aside from having had prior radiotherapy to the treatment site (see exclusion criteria 5.2.3).

• Patient must be ≥ 18 years of age.

• Patient must have a life expectancy ≥ 9 months.

• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

• Patient must have normal organ and marrow function.

• Patient must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study

• Patients receiving any other investigational agents

• Patient who has had any prior radiotherapy to the treatment site(s)

• Patients taking drugs that are contraindicated with nelfinavir, including any of the following:

Amiodarone, Quinidine, Rifampin, Dihydroergotamine, Ergonovine, Ergotamine, Methylergonovine, Hypericum perforatum (St. John's wort), Lovastatin, Simvastatin, Pimozide, Midazolam, Triazolam

• Women of child bearing potential who refuse to take a pregnancy test prior to treatment

• Participation in another concurrent treatment protocol while being treated on this protocol and through to 3 months after treatment on this protocol has ended

• Pregnant women

• Inability to understand the informed consent document

• Inability to sign the informed consent document

• Poor liver function suggestive of cirrhosis or steatohepatitis